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Pfizer recalls Chantix smoking cessation drug over high levels of cancer-causing agents

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Photo by J.B. Reed/Bloomberg via Getty Images

Pfizer Inc. has announced it is recalling all lots of its anti-smoking treatment drug, Chantix, due to what it says are high levels of carcinogens in the pills.

What's a brief history here?

Pfizer in June announced it was pausing distribution of the drug due to the heightened levels of N-nitrosodimethylamine (NDMA) found in some of the drug's lots.

At the time, the biopharmaceutical company said that the pause in distribution was "ordered out of an abundance of caution while further testing [was] is conducted."

What are the details?

According to a Thursday Reuters report, the company announced it would be recalling all lots of Chantix, and asked all wholesalers and distributors to immediately stop the use and distribution of the drug.

A communication from the company read that wholesalers and distributors should "quarantine the product immediately."

The FDA approved Chantix — also known as varenacline — in 2006. The FDA has yet to issue a recall or any statement on Chantix at the the time of this reporting.

In a statement, Pfizer spokesperson Steven Danehy said, "The benefits of Chantix outweigh the very low potential risks, if any, posted by nitrosamine exposure from varenicline on top of other common sources over a lifetime."

A statement from the company, citing communications from the FDA, added, "Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication."

The statement added, "Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time."

"To date, Pfizer has not received reports of adverse events assessed to be related to this recall," the company added. "Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product."

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